Philips North America: System, Nuclear Magnetic Resonance Imaging
Recall Summary Philips is recalling certain Ingenia Elition X MRI machines (models 781358, 782107, and 782136) distributed worldwide because they may produce inaccurate stiffness measurements when using specific image reconstruction settings with MR Elastography technology. The error occurs when default scan protocol settings display incorrect voxel sizes, potentially affecting the accuracy of tissue stiffness readings used in diagnostic imaging. This Class II recall affects healthcare facilities in the US and over 50 other countries that operate these specific MRI systems.
- Recalling firm
- Philips North America
- Product
- Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
- Reason
- The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-14
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b6eaf40a-8993-4c9f-9148-a9317217af37